25 Quality Compliance Specialist Jobs in Irvine, CA
intellectt is Hiring a Quality Compliance Specialist Near Irvine, CA
We have a requirement for Senior Quality Compliance Specialist for one of our medical devices client, If you're interested in this role, you can share your updated resume to narayana@intellectt.com or you can call me at 1 732 769 3774Role: Sr Quality Compliance Spececialist
Location: Remote role.
Duration: 9 Months on W2
Must work in the PST timezone from 8 AM to 5 PM.
Job Description
- Managing complaints for transcatheter heart valve (THV) devices.
- Oversight of safety reporting for global complaints across 100 countries.
- Collaboration with counterparts in Japan and Europe.
- Reviewing adverse events from ongoing clinical studies.
- Familiarity with Microsoft Office suite, Salesforce, and Power BI preferred.
- Assessing the reportability of complaints and investigating incidents with medical professionals; Coordinating with field representatives and nurses to gather clinical insights.
- Generating documentation for investigations and submitting Medical Device Reports (MDRs) to regulatory agencies; Managing multiple projects and meeting regulatory deadlines.
- The training period for this position typically lasts about four months before an individual can begin handling complaints or signing off on complaint processes.
- During this time, they undergo extensive training on various aspects, including the company's quality management system, internal processes, different device malfunctions and adverse events, and regulatory requirements.
- Additionally, they may receive training on specific devices and their functionalities, as well as clinical studies and associated adverse event reporting.
- This comprehensive training ensures that they are fully equipped to handle the responsibilities of the role effectively.
- Bachelor's degree in science, engineering, or related field preferred.
- Minimum of five years of experience in complaint handling for medical devices.
- Knowledge of cardiology and medical device reporting regulations is highly desirable.
- Experience with ATQ database for complaint management.
- Experience in complaint handling for medical devices.
- Proficiency in complaint handling and medical device reporting.
- Proficiency in medical devices reporting to the FDA.
- Familiarity with medical terminology, particularly in cardiology.
- Ability to adapt to changing regulations and processes.
- Initial interview with Hiring Manager, followed by a panel video interview consisting of 4 to 5 members.
Job Summary
Contractor
Business Services
$77k-97k (estimate)
05/30/2024
10/20/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
The job skills required for Quality Compliance Specialist include Microsoft Office, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Compliance Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Compliance Specialist. Select any job title you are interested in and start to search job requirements.
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